Allergy & Immunology
Cohort Study: Lower Risk of Cardiovascular Complications in Post–COVID-19 Vaccine Myocarditis Compared to Conventional Etiologies
7 Sep, 2024 | 20:36h | UTCStudy Design and Population: This French nationwide cohort study included 4,635 individuals aged 12-49 hospitalized for myocarditis between December 2020 and June 2022. The cohort was divided into three groups: 558 patients with post–COVID-19 mRNA vaccine myocarditis, 298 with post–COVID-19 infection myocarditis, and 3,779 with conventional myocarditis.
Main Findings: At 18 months of follow-up, the frequency of cardiovascular events was significantly lower in the postvaccine myocarditis group (5.7%) compared to conventional myocarditis (13.2%) with a weighted hazard ratio (wHR) of 0.55 (95% CI, 0.36-0.86). Hospital readmission for myopericarditis occurred in 3.2% of postvaccine cases, 4.0% of post–COVID-19 cases, and 5.8% of conventional cases. The all-cause mortality rate was 0.2% for postvaccine myocarditis, 1.3% for post–COVID-19 myocarditis, and 1.3% for conventional myocarditis.
Implications for Practice: Postvaccine myocarditis patients, primarily young males, experience fewer complications compared to conventional myocarditis, but long-term follow-up is still needed. These findings should guide future mRNA vaccine recommendations and clinical management for myocarditis patients.
Reference: Semenzato L. et al. (2024). Long-term Prognosis of Myocarditis Attributed to COVID-19 mRNA Vaccination, SARS-CoV-2, or Conventional Etiologies. JAMA, Online. DOI: http://doi.org/10.1001/jama.2024.16380
Link: https://jamanetwork.com/journals/jama/fullarticle/2822933
RCT: Zasocitinib Achieves Significant Psoriasis Improvement in Moderate to Severe Plaque Psoriasis
6 Sep, 2024 | 22:48h | UTCStudy Design and Population: This phase 2b, double-blind, placebo-controlled trial evaluated the efficacy, safety, and tolerability of zasocitinib, a selective tyrosine kinase 2 (TYK2) inhibitor, in patients with moderate to severe plaque psoriasis. Conducted across 55 centers in the US and Canada, the study enrolled 287 patients aged 18 to 70 years with a Psoriasis Area and Severity Index (PASI) score ≥12, and ≥10% of body surface area affected. Patients were randomized to receive zasocitinib at doses of 2 mg, 5 mg, 15 mg, or 30 mg, or a placebo, over 12 weeks.
Main Findings: At week 12, significant improvements in PASI were observed across all doses of zasocitinib. The primary endpoint of PASI 75 was achieved in 18%, 44%, 68%, and 67% of patients in the 2 mg, 5 mg, 15 mg, and 30 mg zasocitinib groups, respectively, compared to 6% in the placebo group. Higher PASI 90 and PASI 100 responses were also observed, particularly in the 15 mg and 30 mg groups. Adverse events were mild to moderate and occurred in 53% to 62% of patients receiving zasocitinib, compared to 44% for placebo.
Implications for Practice: Zasocitinib shows promise as an effective and well-tolerated oral treatment for moderate to severe plaque psoriasis. Its efficacy in achieving skin clearance (PASI 75 and above) at higher doses suggests potential for broader clinical use, with phase 3 trials warranted for further validation.
RCT: Azithromycin Increases Asthma Remission Rates in Adults With Persistent Uncontrolled Asthma
6 Sep, 2024 | 22:35h | UTCStudy Design and Population: This secondary analysis stems from the Asthma and Macrolides: Azithromycin Efficacy and Safety (AMAZES) trial, a randomized, double-anonymized, placebo-controlled trial. The study involved 335 adults with persistent uncontrolled asthma, who were treated with either azithromycin (500 mg, 3 times weekly) or placebo for 12 months. The goal was to evaluate azithromycin’s impact on asthma remission, defined through clinical and lung function measures.
Main Findings: Azithromycin significantly increased the rate of clinical remission compared to placebo (50.6% vs. 38.9%; P = .032). Clinical remission combined with lung function criteria was also higher in the azithromycin group (50.8% vs. 37.1%; P = .029). Although the complete remission rate (including sputum eosinophil count <3%) trended higher, it did not reach statistical significance (23% vs. 13.7%; P = .058).
Implications for Practice: This secondary analysis suggests that azithromycin, when added to standard asthma therapy, could significantly increase remission rates in adults with persistent uncontrolled asthma, including both eosinophilic and noneosinophilic subtypes.
News Release – FDA Approves First Nasal Spray for Anaphylaxis Treatment: Neffy (Epinephrine Nasal Spray) – U.S. Food and Drug Administration
17 Aug, 2024 | 15:43h | UTCThe U.S. Food and Drug Administration (FDA) has approved Neffy, the first epinephrine nasal spray for the emergency treatment of anaphylaxis and other severe allergic reactions (Type I) in both adults and pediatric patients weighing at least 30 kilograms (approximately 66 pounds). This approval introduces a non-injectable option for the rapid administration of epinephrine, which is critical in managing life-threatening allergic reactions.
Key Points for Healthcare Providers:
– Alternative to Injection: Neffy provides a new option for patients who may delay or avoid epinephrine injections due to needle phobia. This could be particularly beneficial for children and others reluctant to use injectable epinephrine.
– Efficacy and Safety: Neffy’s approval is supported by studies comparing its pharmacokinetics and pharmacodynamics to traditional epinephrine injections. These studies showed comparable blood epinephrine levels and similar physiological effects, such as increased blood pressure and heart rate.
– Administration: Neffy is a single-dose nasal spray, administered into one nostril. If symptoms do not improve or worsen, a second dose may be administered in the same nostril. Patients should still seek emergency medical care to monitor the anaphylactic reaction.
– Warnings: Certain nasal conditions, such as nasal polyps or a history of nasal surgery, may impair Neffy’s absorption. In these cases, injectable epinephrine might be a more reliable option. The product also carries typical warnings for epinephrine use, particularly in patients with coexisting conditions.
– Side Effects: Common side effects include throat irritation, nasal discomfort, headaches, and jitteriness. Healthcare professionals should discuss these with patients to ensure informed use.
Clinical Implications:
Neffy may reduce barriers to the timely treatment of anaphylaxis, potentially improving outcomes by increasing the likelihood of rapid epinephrine administration. Healthcare providers should consider Neffy as an alternative for patients who are needle-averse or have difficulty using injectable epinephrine, while also ensuring patients understand the importance of prompt medical attention following its use.
Approval Background:
Neffy was granted Fast Track designation by the FDA, emphasizing the need for an alternative to injectable epinephrine. The approval was awarded to ARS Pharmaceuticals.
Source: FDA News Release: FDA Approves First Nasal Spray for Treatment of Anaphylaxis
RCT: Nemolizumab Plus Topical Therapy Improves Skin Clearance, Itch, and Sleep in Moderate-to-Severe Atopic Dermatitis – The Lancet
11 Aug, 2024 | 12:58h | UTCStudy Design and Population: This study reports on two identical 48-week, double-blind, randomized, placebo-controlled phase 3 trials (ARCADIA 1 and ARCADIA 2) involving 1,728 adolescents and adults with moderate-to-severe atopic dermatitis and pruritus unresponsive to topical corticosteroids. Participants were randomized 2:1 to receive nemolizumab (an IL-31 receptor antagonist) or placebo, alongside background topical corticosteroids (TCS) and/or calcineurin inhibitors (TCI).
Main Findings: At week 16, nemolizumab significantly improved primary outcomes compared to placebo, with a higher proportion achieving clear or almost clear skin (IGA success) and a 75% improvement in Eczema Area and Severity Index (EASI-75). Nemolizumab also showed significant early and sustained improvements in itch and sleep. The safety profile was comparable between groups, with treatment-emergent adverse events occurring in about half of the participants.
Implications for Practice: Nemolizumab, in combination with TCS-TCI, demonstrated robust efficacy in reducing inflammation, itch, and sleep disturbances in moderate-to-severe atopic dermatitis. If approved, it could provide an important addition to current treatment options, particularly for patients inadequately managed by existing therapies.
Nested Case-Control Study: Sulfonamide Antibiotics and Cephalosporins Linked to Highest Risk of Serious Cutaneous Adverse Drug Reactions – JAMA
10 Aug, 2024 | 21:16h | UTCStudy Design and Population: This population-based, nested case-control study assessed the risk of serious cutaneous adverse drug reactions (cADRs) among older adults (66 years and above) in Ontario, Canada, who received oral antibiotics between 2002 and 2022. The study included 21,758 cases of emergency department visits or hospitalizations for serious cADRs, matched with 87,025 controls.
Main Findings: The study found that sulfonamide antibiotics (adjusted odds ratio [aOR], 2.9) and cephalosporins (aOR, 2.6) posed the highest risk of serious cADRs compared to macrolides. Nitrofurantoin, penicillins, and fluoroquinolones also showed elevated risks. Cephalosporins had the highest crude rate of cADRs (4.92 per 1,000 prescriptions).
Implications for Practice: The findings suggest that clinicians should consider the higher risks of serious cADRs associated with sulfonamide antibiotics and cephalosporins when prescribing antibiotics, opting for lower-risk alternatives when appropriate.
Diagnostic Study: Enhanced prediction of TB progression with IGRAs compared to tuberculin skin test
27 Apr, 2024 | 18:53h | UTCStudy Design and Population:
This prospective diagnostic study analyzed the predictive accuracy of tuberculosis (TB) tests among 22,020 high-risk participants across 10 US sites from 2012 to 2020. Participants included individuals with close contacts to infectious TB cases, those born in or travelers to high-incidence countries, individuals living with HIV, or belonging to locally prevalent high-risk groups. Testing included two interferon-γ release assays (IGRAs), QuantiFERON-TB Gold In-Tube (QFT-GIT) and SPOT.TB (TSPOT), alongside the traditional tuberculin skin test (TST).
Main Findings:
The study found that both IGRAs, TSPOT and QFT-GIT, showed significantly superior positive predictive value (PPV) for predicting TB disease progression compared to the TST, with PPV ratios of 1.65 (95% CI, 1.35-2.02) and 1.47 (95% CI, 1.22-1.77) respectively. Additionally, when considering a positive TST result, further positive results from either IGRA significantly increased the PPV, emphasizing the enhanced predictive capability of IGRAs over TST alone.
Implications for Practice:
The superior predictive performance of Interferon-γ Release Assays (IGRAs) suggests they should be considered in clinical settings for high-risk populations, if available and feasible, to better identify individuals at increased risk of progressing to active tuberculosis (TB). This enhanced detection capability could guide more targeted preventive treatments, ultimately supporting global efforts toward TB elimination. Clinicians should assess the accessibility and cost-effectiveness of IGRAs to refine decision-making processes in TB prevention strategies, ensuring that the benefits of these advanced diagnostics are balanced against their costs.
Reference (free full-text):
Study | Removal of thymus in adults linked to increased death, cancer incidence
4 Aug, 2023 | 12:09h | UTCHealth Consequences of Thymus Removal in Adults – New England Journal of Medicine (link to abstract – $ for full-text)
Commentaries:
Doctors have long considered the thymus expendable. But could removing it be fatal? – Science
The thymus withers away after puberty. But it may be important for adults – Science News
Thymus gland critical for adult health, study finds – News Medical
Commentary on Twitter
In a study by Kooshesh et al., mortality, the risk of cancer, and levels of proinflammatory cytokines were higher among adults whose thymus had been removed than among control patients. Read the full study results: https://t.co/poaAiELsKG
— NEJM (@NEJM) August 2, 2023
Review | Autoimmunity and postural orthostatic tachycardia syndrome: Implications in diagnosis and management
4 Aug, 2023 | 11:49h | UTC
RCT | Maternal egg intake in early neonatal period does not impact infant egg allergy risk
2 Aug, 2023 | 13:47h | UTCSee also: Visual Abstract
An ESPGHAN position paper on the diagnosis, management and prevention of cow’s milk allergy
31 Jul, 2023 | 14:28h | UTC
Systematic Review | Medical treatment of eosinophilic esophagitis
21 Jul, 2023 | 13:27h | UTCMedical treatment of eosinophilic esophagitis – Cochrane Library
Summary: Medical treatments for eosinophilic esophagitis – Cochrane Library
Related:
M-A | Efficacy of elimination diets in eosinophilic esophagitis
RCT | Dupilumab in adults and adolescents with eosinophilic esophagitis
RCT | Direct oral challenge noninferior to skin testing followed by direct oral challenge in low-risk penicillin allergy patients
18 Jul, 2023 | 13:54h | UTCEfficacy of a Clinical Decision Rule to Enable Direct Oral Challenge in Patients With Low-Risk Penicillin Allergy: The PALACE Randomized Clinical Trial – JAMA Internal Medicine (free for a limited period)
See also: Visual Abstract
News Release: World-first clinical trial to help millions with penicillin allergies – Vanderbilt University Medical Center
Commentary: Trial supports use of direct oral challenge for penicillin allergy – CIDRAP
Guideline | Antibiotic therapy in patients with suspected antibiotic allergy
17 Jul, 2023 | 13:59h | UTC
Guidelines | Management of atopic dermatitis in adults with topical therapies
14 Jul, 2023 | 12:48h | UTC
Impact of newborn screening on severe combined immunodeficiency survival: results from a 36-year longitudinal study
14 Jul, 2023 | 12:45h | UTCMeasuring the effect of newborn screening on survival after haematopoietic cell transplantation for severe combined immunodeficiency: a 36-year longitudinal study from the Primary Immune Deficiency Treatment Consortium – The Lancet (link to abstract – $ for full-text)
Commentary on Twitter
Findings from a 36-year longitudinal study provide direct evidence that newborn screening for SCID has been the primary driver of improved survival in new-born babies in the USA and Canada since 2010.
Read the full article: https://t.co/TAAcPztpF9 pic.twitter.com/cOxvNNJmb9
— The Lancet (@TheLancet) July 12, 2023
Review | Hypereosinophilic syndrome (HES) and eosinophilic granulomatosis with polyangiitis (EGPA): two sides of the same coin
7 Jul, 2023 | 16:01h | UTCHES and EGPA: Two Sides of the Same Coin – Mayo Clinic Proceedings
Podcast | Wisely ordering autoantibodies
28 Jun, 2023 | 13:09h | UTC#399 Wisely Ordering Autoantibodies – ACP IM2023 – The Curbsiders
Adrenaline auto-injector prescription for patients at risk of anaphylaxis: BSACI guidance for primary care
6 Jun, 2023 | 14:28h | UTC
RCT | Dupilumab improves lung function and reduces exacerbations in COPD patients with elevated eosinophils
1 Jun, 2023 | 12:20h | UTCDupilumab for COPD with Type 2 Inflammation Indicated by Eosinophil Counts – New England Journal of Medicine (link to abstract – $ for full-text)
Commentary: Dupilumab Improves Outcomes for COPD, Type 2 Inflammation in Randomized Trial – HCP Live
Commentary on Twitter
Presented at #ATS2023: In the BOREAS trial, dupilumab resulted in a lower annualized rate of exacerbations than placebo among patients with COPD and an elevated blood eosinophil count. Full trial results: https://t.co/9IWZr3YqsN
— NEJM (@NEJM) May 21, 2023
Guideline | Investigation and management of acute transfusion reactions
29 May, 2023 | 11:02h | UTC
RCT | Peanut patch therapy is effective in desensitizing young children with allergies, but raises risk of serious adverse events
15 May, 2023 | 13:10h | UTCPhase 3 Trial of Epicutaneous Immunotherapy in Toddlers with Peanut Allergy – New England Journal of Medicine (link to abstract – $ for full-text)
Commentary on Twitter
In the phase 3 EPITOPE trial involving children 1 to 3 years of age with peanut allergy, epicutaneous immunotherapy by means of a peanut patch was superior to placebo in desensitizing children to peanut. https://t.co/USk6HBI9Qh#pediatrics
— NEJM (@NEJM) May 10, 2023
Cohort Study | Autoimmune disorders’ incidence, prevalence & co-occurrence by age, sex, and socioeconomic status
8 May, 2023 | 13:14h | UTCIncidence, prevalence, and co-occurrence of autoimmune disorders over time and by age, sex, and socioeconomic status: a population-based cohort study of 22 million individuals in the UK – The Lancet (free for a limited period)
Commentary from the author on Twitter (thread – click for more)
Our latest research is out in @TheLancet today
We sought to answer:
1. Are autoimmune diseases on the rise as has been suggested?
2. Can we identify clues as to their causes (genetic or environmental)?
3. Do different autoimmune diseases cluster together & what might this mean? pic.twitter.com/noCpPpo8FU— Nathalie Conrad (@nathalie_conrad) May 6, 2023
Cohort Study | Idiopathic CD4 Lymphocytopenia linked to increased infection risk and cancer prevalence
5 May, 2023 | 15:16h | UTCReappraisal of Idiopathic CD4 Lymphocytopenia at 30 Years – New England Journal of Medicine (link to abstract – $ for full-text)
Commentary on Twitter
Idiopathic CD4 lymphocytopenia was initially described approximately 30 years ago as #HIV infections were emerging. In this report, longer-term characteristics of this syndrome are described. https://t.co/kV45SKmRQv#InfectiousDisease
— NEJM (@NEJM) May 3, 2023
RCT | Efficacy and safety of tralokinumab in adolescents with moderate to severe atopic dermatitis
3 May, 2023 | 15:04h | UTCCommentary: Tralokinumab Efficacious, Well-Tolerated for Adolescents with Atopic Dermatitis – HCP Live
Commentary on Twitter
The ECZTRA 6 trial showed that targeted IL-13 inhibition with tralokinumab was efficacious and well tolerated in adolescents with moderate-to-severe AD, suggesting that it is a valuable treatment option in this age group. https://t.co/h36BW4XThE
— JAMA Dermatology (@JAMADerm) April 19, 2023